AVANTI - Avelox® in Acute Exacerbations of chroNic bronchiTIs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2672 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-04-30

Brief Summary

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The objective of this global non-interventional study is to evaluate the impact of Acute Exacerbation of Chronic Bronchitis(AECB) on the patient and the community as well as the safety and effect of a treatment with Moxifloxacin tablets in daily life clinical practice. This includes data on the course of symptom relief, speed of return to normal daily life activities as well as records on adverse events.

This study will be performed in accordance with international guidelines like EMEA (EMEA, EUDRALEX Volume 9A, Pharmacovigilance for Medicinal Products for Human Use) as well as local laws.

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Detailed Description

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Conditions

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Bronchitis, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Moxifloxacin (Avelox, BAY12-8039)

Intervention Type DRUG

Patients with acute exacerbation of chronic bronchitis for whom the physician decided to prescribe moxifloxacin

Interventions

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Moxifloxacin (Avelox, BAY12-8039)

Patients with acute exacerbation of chronic bronchitis for whom the physician decided to prescribe moxifloxacin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients at least 35 years of age with a diagnosis of Acute Exacerbation of Chronic Bronchitis (AECB) and decision taken by the investigator to treat with Avelox.

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Bayer HealthCare AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Albania

Site Status

Many Locations, , Bosnia and Herzegovina

Site Status

Many Locations, , Kazakhstan

Site Status

Many Locations, , Moldova

Site Status

Many Locations, , North Macedonia

Site Status

Many Locations, , Russia

Site Status

Many Locations, , Slovakia

Site Status

Many Locations, , Ukraine

Site Status

Countries

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Albania Bosnia and Herzegovina Kazakhstan Moldova North Macedonia Russia Slovakia Ukraine

References

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Chuchalin A, Zakharova M, Dokic D, Tokic M, Marschall HP, Petri T. Efficacy and safety of moxifloxacin in acute exacerbations of chronic bronchitis: a prospective, multicenter, observational study (AVANTI). BMC Pulm Med. 2013 Jan 23;13:5. doi: 10.1186/1471-2466-13-5.

Reference Type DERIVED

PMID: 23343427 (View on PubMed)